Our service include
Database Design and Implementation
Customized design and implementation of clinical databases, using validated EDC systems tailored to the specific needs and regulatory requirements of each study.
Data Validation and Quality Assurance
Comprehensive validation processes, including advanced edit checks, query management, and discrepancy resolution to secure high-quality, analysis-ready datasets.
Secure Data Handling and Regulatory Compliance
Strict adherence to GCP standards and data protection regulations (GDPR, nLPD), ensuring the secure handling, storage, and controlled transfer of clinical data throughout the study lifecycle.
Data Archiving and Retention
Structured, compliant archiving of all clinical data and documents, supporting regulatory inspections, audits, and long-term data integrity.
Preparation for Statistical Analysis
Efficient preparation and delivery of validated datasets, fully ready for robust statistical analysis and regulatory reporting.
With GALSER, you can trust that your clinical data is managed with precision, transparency, and full regulatory compliance.
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